FITTING INSTRUCTIONS FOR THE HEALTH CARE PROFESSIONAL
Gellhorn Silicone
Multiple Drain Pessary
gellhorn
• Fitting diaphragms should not be used to measure the size pessary
a patient will need. Diaphragms fit differently from pessaries.
• Even before fitting a pessary, the patient should be informed that it is
not uncommon to have to change the size or type of pessary more
than once after being originally fitted. This is why it is so important
that your patient be instructed to return within 24 hours of the initial
fitting and again in 72 hours. Thereafter, re-examination every few
months is recommended to ensure that a proper fit is maintained as
long as the patient is wearing the pessary.
Fitting Instructions for the
Health Care Professional
Patient instructions enclosed
Single-Patient Use
Silicone
(Latex Free)
English
Support for third-degree prolapse/procidentia
0086
Wash Pessary with mild soap and thoroughly
rinse prior to initial use.
CAUTION: U.S. Federal law restricts this device to sale
by or on the order of a physician.
Made in the USA
95 Corporate Drive
Trumbull, CT 06611 USA
Phone: (800) 243-2974
Fax: (800) 262-0105
EC
REP
International
Phone: (203) 601-9818
Fax: (203) 601-4747
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
www.coopersurgical.com
DESCRIPTION
The GELLHORN multiple drain pessary is available in two stem lengths:
Standard Stem and Short Stem. The Short Stem is approximately ½ inch
shorter than the Standard Stem.
AVAILABLE MODELS
• At the physician’s discretion, the patient can be instructed in the
proper removal, cleaning and reinsertion techniques for her own
pessary. This process can be performed nightly by the patient under
ideal circumstances.
• The INFLATOBALL™, CUBE and TANDEM-CUBE pessaries are the
three exceptions to the above. Patients must be instructed to insert,
remove and clean these pessaries daily.
• The CUBE and TANDEM-CUBE pessaries fill the entire vaginal vault
and have no area for drainage. The INFLATOBALL pessary should
not be left in place more than 24 consecutive hours.
• A noncompliant patient should not be fitted with any pessary. It is
essential that your patient understands the importance of these frequent
follow-up visits and that she fully cooperates with you to ensure the
desired results.
Note: Each type of pessary is available in a wide range of sizes – most
pessaries are made in 9 to 14 different sizes.
INDICATIONS:
For effective support of third-degree uterine prolapse or procidentia. The
cervix rests behind the flat base of the pessary and only the stem shows
in the vaginal entrance when the patient does a Valsalva maneuver.
The GELLHORN pessary requires a relatively capacious vagina and
an intact perineum.
Folding Silicone Gellhorn Pessary
REF MXKPGE + Size (Standard Stem)
CONTRAINDICATIONS:
• The presence of pelvic infections or lacerations
REF MXKPGSS + Size (Short Stem)
• Since the GELLHORN pessary is difficult for the patient to remove, it
is also contraindicated in any sexually active patient.
95% Rigid Silicone Gellhorn Pessary
• A noncompliant patient
• Endometriosis has been suggested as a possible contraindication to
pessary use.
REF MXKPGRS + Size
To properly fit a patient with a GELLHORN pessary it is necessary to have
available a minimum of four sizes. The shaded area indicates sizes
recommended for office fitting. With these sizes you will be able to fit
approximately 85% of patients.
AVAILABLE IN THE FOLLOWING SIZES:
DIAMETER
DIAMETER
1-1/2”
38mm
1-3/4”
2”
2-1/4”
2-1/2”
• At each visit the pessary should be removed and the vaginal vault
inspected for signs of allergic reaction or undue pressure.
Experience has shown that in order to properly fit a GELLHORN
pessary, you should have available each of the four most commonly
used sizes in this pessary (see the size chart).
37793 • Rev. A • 9/12
CPT CODE:
IMPORTANT
• Pessaries are fitted by trial and error. There are no mechanical
devices available that can accurately determine the size or type of
pessary your patient requires to obtain the desired results.
2-3/4”
70mm
44mm
3”
76mm
51mm
3-1/4”
83mm
57mm
3-1/2”
89mm
64mm
3-3/4”
95mm
Procedure: 57160
• Health care professionals should use their professional judgment as
to the advisability of using this pessary in a pregnant patient.
LATEX-FREE CURRENT SILICONE INFORMATION:
CooperSurgical has had nontoxic silicone gynecologic devices available
for hyper-allergic patients for more than 10 years.
ADVANTAGES OF SILICONE:
1. Longer shelf life and use life.
2. Can be autoclaved.
PESSARY CARE:
Pessaries are powdered with food-grade powder. The powder must be
washed off with a mild soap and the pessary thoroughly rinsed with
water and dried prior to initial use.
HCPCS: A4562
37793 • Rev. A • 9/12
Prior to insertion of any pessary, it is important to thoroughly clean and
remove any matter that may be on the outer surface. CooperSurgical
recommends washing with mild soap and thoroughly rinsing with water
prior to initial use. Although there is no need to sterilize the pessary for
single patient use, best-practice suggests that a sterilization cycle is
performed to provide an extra degree of assurance when initially fitting
the pessary. We find this practice is a good policy to avoid any
inadvertent contamination.
4. Once the large flat disc is past the
introitus, push the pessary
upward until only the end of the
stem shows in the vaginal
entrance. The cervix rests behind
the flat disc (see Figure 2).
Fitting Pessaries: The yellow Milex fitting pessaries are designed to be
used in the physician’s office for selecting and fitting the correct pessary
for individual patient use and should only be worn in 15 minutes
increments, as many of the fitting pessaries do not have nylon pegs for
support. The yellow fitting pessaries should be cleaned and sterilized prior
to fitting each patient but do not need to be stored in a sterile environment.
5. Have the patient sit, stand and bear down. Examine the patient while
she is in the standing position to ensure the pessary has not shifted
position. The patient should not feel the pessary once it is in position.
The pessary should not be too loose as it may turn or be expelled
and it should not be too tight as it may cause discomfort.
With the realization that many different techniques are practiced in the
health care community, we attempted to optimize methods to afford the
best coverage for our customers. Every facility should validate its own
equipment and parameters before processing any medical device.
RECOMMENDED CLEANING BEFORE INSERTION
• Decontamination/Disinfection: CIDEX® OPA for 12 minutes
• The agent must be thoroughly rinsed off with water.
RECOMMENDED STERILIZATION BEFORE INSERTION
Pre-vacuum: 270 °F – 275 °F (132 °C – 135 °C) for 4 minutes
Gravity displacement: 250 °F – 255 °F (121 °C – 124 °C) for 40 minutes
PRIOR TO FITTING:
Have the patient empty her bladder before fitting this pessary.
Ulcerations and erosions frequently occur in cases of complete prolapse
due to irritation of the exteriorized cervix.
Whenever possible, reducing the mass and treating the irritation are
primary steps before using a pessary.
The only method of determining the proper size GELLHORN pessary is
trial and error. The holes allow for drainage without reducing the
effectiveness of the pessary. The unique silicone folding design facilitates
simple insertion and removal. Unlike latex rubber, silicone does not absorb
secretions or emit odors.
Figure 2
6. The health care professional should be able to sweep one finger
between the pessary and vaginal walls. If there is not enough space
to do this, the next smaller size should be tried. If excessive space
exists, the pessary will not be effective and may rotate or even be
expelled.
7. It may be necessary to refit the patient with a different size or type
of pessary after a period of time. Do not assume that a replacement
will always be the same size as the previous one. Check the fitting
to ensure continued patient comfort and relief of symptoms.
The use life of a pessary is limited. Examine the pessary for signs
of deterioration.
PATIENT FOLLOW-UP:
Have the patient:
• Report immediately any difficulty in urinating
• Report immediately any discomfort
• Return within 24 hours for first examination
• Return for second examination within 3 days
• Return for examination every few months
Note: Above schedule of follow-up examinations may be altered to fit
the needs of the individual patient.
TO REMOVE:
INSTRUCTIONS FOR USE
1. Use one finger to depress the perineum.
STEP-BY-STEP FITTING INSTRUCTIONS FOR THIS PESSARY
2. Use other hand to grasp the “knob,”
pulling the pessary away from the cervix,
turning the pessary so that the disc is
almost parallel to the introitus. Using
corkscrew motion ease the pessary out.
See Figure 3.
Note: We recommend the GELLHORN pessary be inserted and removed
by a physician or other health care professional. In general, the largest
pessary the patient can comfortably accommodate should be fitted.
Perform a normal pelvic examination before inserting or fitting any pessary.
A first approximation of size can be made by using your fingers to
determine the approximate width of the vaginal vault. This will generally
get you within a size or two of the proper pessary.
Note: If necessary, irrigate the vagina prior to insertion of the pessary.
This will cleanse the vagina of excess discharge and secretions. HCPCS
Supply Number A4320 (Irrigation Tray with Syringe, any purpose).
The GELLHORN pessary requires a relatively capacious vagina and an
intact perineum.
1. Wear dry gloves. When necessary, lubricate
only the entering end of the pessary with
TRIMO-SAN™ or other suitable lubricant.
Hold the pessary as shown in Figure 1.
2. Use one finger to depress the perineum.
Stem
3. Wash the pessary with mild soap and
water and rinse thoroughly.
Figure 3
4. Thoroughly rinse the stem channel.
Note: If necessary, irrigate the vagina after removing the pessary (and before
reinserting) to cleanse the vagina of excess discharge and secretions.
During each visit, the vagina should be carefully inspected for evidence
of pressure or allergic reaction. The patient should be questioned
concerning douching, discharge, and disturbance of bowel function or
urination. It may be necessary to fit another size or an entirely different
shape pessary.
DO NOT assume that a replacement will always be the same size as
the previous one. Check the fitting to ensure continued patient comfort
and relief of symptoms.
Disc
Figure 1
3. Guide the pessary, inserting it edgewise almost parallel to the introitus
(see Figure 1), avoiding the urethral opening while the perineum is
strongly pushed downward. Use a corkscrew motion while introducing
the GELLHORN into the vagina.
At each checkup, the pessary should be removed and cleaned. If there
are no contraindications, the pessary may be reinserted.
WARNING: Chemicals in various vaginal preparations can interact with
the pessary material, resulting in discoloration or deterioration of the
pessary. TRIMO-SAN does not interact with the pessary material. Use
only TRIMO-SAN; other materials have not been tested for compatibility.
37793 • Rev. A • 9/12
PURPOSE OF TRIMO-SAN:
1. To help restore and maintain normal vaginal acidity.
2. To coat the walls of the vagina with a lubricating film that helps reduce
odor-causing bacteria.
APPLICATION:
A
• Pessary wearers should use 1/2 applicator of TRIMO-SAN three (3)
times the first week after original insertion of the pessary, unless
otherwise directed by the health care professional.
D
H
• Use 1/2 applicator of TRIMO-SAN twice a week thereafter, unless
otherwise directed by the health care professional.
G
E
• Reaction or irritation caused by TRIMO-SAN is very rare, but should it
occur, discontinue use.
C
B
L
K
F
TRIMO-SAN HAS NOT BEEN TESTED DURING PREGNANCY:
• If the patient wishes to become pregnant, please advise her against
using TRIMO-SAN or any other personal hygiene product (douches,
vaginal sprays, jellies or suppositories) for 6 hours prior to or following
intercourse. Any product used within this time period could interfere
with conception.
I
J
N
• If symptoms persist or worsen, contact your health care professional.
X
U
T
M
R
S
O
W
Q
P
V
SUGGESTION: Advise your patient that TRIMO-SAN is available at the
prescription counter upon request (no Rx required).
(SEE PACKAGE INSERT FOR TRIMO-SAN USE
COMPLETE DIRECTIONS)
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
HAVE PATIENT REPORT ANY OF THE FOLLOWING SYMPTOMS:
• Any difficulty urinating
• Any changes in the color or consistency of vaginal discharge
• Any increase in amount of vaginal discharge
• Any foul odor associated with vaginal discharge
• Vaginal itching
For medical emergencies and for all other medically-related advice, consult
your health care professional.
Review separate instructions with the patient to establish use regimen.
EXPLANATION OF SYMBOLS
Catalog Number
Batch Code
Use By (year, month)
Latex Free
ATTENTION:
See instructions for use.
Cube w/Drainage Holes
Cube
Tandem-Cube
Gehrung
Gehrung w/Knob
Regula
Hodge w/Knob
Hodge w/Support
Risser
Hodge
Smith
Hodge w/Support & Knob
Ring w/Support
Ring w/Support & Knob
Ring w/Knob
Ring
Gellhorn - Long Stem
Gellhorn - Short Stem
Incontinence Ring
Incontinence Dish
Incontinence Dish w/Support
Donut
Shaatz
Inflatoball
CAUTION: U.S. Federal law restricts this device to sale by
or on the order of a physician.
EC REP
Authorized Representative in the European Community.
CIDEX® is a registered trademark of Johnson & Johnson.
0086
Product conforms to the Medical Device Directive
93/42/EEC.
Milex™, TRIMO-SAN™ and INFLATOBALL™ are trademarks of CooperSurgical, Inc.
CooperSurgical is a registered trademark of CooperSurgical, Inc.
© 2012 CooperSurgical, Inc.
Made in the USA
95 Corporate Drive
Trumbull, CT 06611 USA
Phone: (800) 243-2974
Fax: (800) 262-0105
International
Phone: (203) 601-9818
Fax: (203) 601-4747
EC
REP
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
www.coopersurgical.com
37793 • Rev. A • 9/12
Ett dotterbolag till
Solann AB
Solann AB - www.solann.se - 08 583 560 60